Hepatocellular Carcinoma
Conditions
Keywords
Laparoscopic Middle hepatic vein Hepatocellular carcinoma
Brief summary
The study, entitled RCT study of laparoscopic middle hepatic venous guidance versus conventional ananatomical hemihepatectomy, was designed to compare the efficacy of two different ananatomical hemihepatectomy procedures under laparoscopy.
Detailed description
Backgroud & Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases, which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them, anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to observe and compare the perioperative period and follow-up results of the two different laparoscopic surgical resection methods, and to provide high-level evidence-based medicine evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.
Interventions
PROCEDURElaparoscopic middle hepatic vein guidance anatomic hemihepatectomy
95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Two different treatments are conducted on the participant base on the randomized choices
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. the site was limited to the patients who were suitable for dissecting hemihepatectomy； 2. the type of disease was limited to hepatocellular carcinoma； 3. the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery； 4. child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion； 5. the subjects who participated in this study indicated that they were willing to accept the two surgical methods and agreed to be randomly divided into groups during the operation； 6. 18 ≤ age ≤ 70, male or female.
Exclusion criteria
1. preoperative liver function Child-pugh grade B or C; 2. patients with poor general condition and could not tolerate pneumoperitoneum or anesthesia; 3. patients with severe liver cirrhosis, portal hypertension and lesions invading liver porta; 4. patients with other treatment methods such as radio frequency ablation in addition to dissecting hepatectomy; 5. repeated abdominal operations resulting in severe abdominal adhesion, unable to perform laparoscopic hepatectomy; male and female are not limited
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 3 years | follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative results | Duration perioperation(an expected average of 3 days) | the angle of hepatic vein between segment Ⅳ b and Ⅴ, angle between MHV and IVC |
| intraoperative parameters | during the operation | blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c㎡） |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative complications | Duration hospitalization(an expected average of 7 days) | hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiopulmonary insufficiency，liver function failure |
Countries
China
Contacts
Primary ContactShuguo Zheng, M.D.
Backup ContactShuguo Zheng, Zheng
Outcome results
None listed